AMR
Antimicrobial use positively associated with Key quality indicators for appropriate antibiotic
hospital-onset Clostridioides difficile infections use developed using the Delphi procedure
Clostridioides difficile infections (CDIs), previously asso- Researchers in the Republic of Korea conducted a sys-
ciated with increased antibiotic use, have been declared tematic literature review to identify quality indicators
an urgent public health threat by the CDC. Researchers (QIs) to measure the appropriateness of antibiotic ther-
from CDC used hospital discharge and inpatient charge apy, identify targets for improvement, and evaluate the
records from the Premier Healthcare Database to reassess effects of antibiotic stewardship interventions. Potential
this association. Among the 921 participating hospitals, 50 indicators were evaluated by a multidisciplinary expert
additional days of antibiotic therapy (particularly, carbap- panel and out of 23 identified QIs, six and three (1, 2,
enems, cephalosporins, and piperacillin-tazobactam) per and 5) QIs were deemed as key for inpatients and out-
1,000 patient days were associated with a 2.8% increase in patients, respectively: (1) prescribe empirical antibiotic
the rate of hospital-onset CDIs. In contrast, hospitals that therapy according to existing guidelines, (2) change em-
decreased total antibiotic use by at least 30% demon- pirical antibiotics to pathogen-directed therapy, (3) ob-
strated a 40% decrease in their infection rates. Reductions tain culture samples from suspected infection sites, (4)
in the combined use of cephalosporins, fluoroquinolones, obtain two blood cultures, (5) adapt antibiotic dosage to
and carbapenems could decrease hospital-onset CDIs. renal function, and (6) document antibiotic plan.
Clarithromycin resistance is likely to decrease if Human antibiotic use as key driver
macrolides were used only for H. pylori eradication of antibacterial resistance
Researchers from Semmelweis University in Hungary led a Researchers at the University of Bristol developed a com-
retrospective observational study to determine the prima- partment model incorporating a One Health approach to
ry clarithromycin resistance (Cla-res) rate in a large cohort compare contributions to AMR from human and animal
of Helicobacter pylori-infected patients. The study showed welfare and the environment and identify any possible
that Cla-res was found in 5.5% of macrolide-naive patients interactions that may ultimately impact AMR in human
(primary Cla-res), and a mathematical model estimated populations. Human antibiotic consumption was es-
that this primary Cla-res originated from the transmission timated to be the biggest driver of AMR. Even though
of resistant bacteria in 98.7% of cases and spontaneous reductions in all sectors would significantly impact the
mutations in the other 1.3%. The association between age emergence of AMR, reductions in human consumption
and gender among secondary (acquired) Cla-res infec- were estimated as 13 times more impactful than reduc-
tions was predominantly associated with macrolides’ prior tions in animal consumption.
use for non-eradication purposes, suggesting that Cla-res
prevalence would likely decrease if macrolides were no Mass and systematic antibiotic administration
longer used for purposes other than H.pylori eradication. may increase antibiotic resistance in low
and middle-income countries
One Health approach should be implemented in
medical education and clinical practice Efforts to control infectious diseases spread among com-
CDDEP researchers and other experts in One Health pol- munities in low- and middle-income countries (LMIC) by
icy examined issues relevant to One Health approaches
through examples of challenges and successes to guide mass and systematic antibiotic administration (MDA/
application in clinical practice. Specifically, the experts em-
phasized the need to better implement One Health educa- SDA) may come with the price of increasing antibiotic
tion in medical schools to address knowledge and training
gaps on environmental health and management of zoon- resistance. As MDA/SDA interventions target vulnerable
oses. The recommendations provided by the expert panel
fell under four broad categories: 1) improve One Health re- groups of the population overrepresented in LMIC, some
source sharing in global health and medical education, 2)
create pathways for information flow in clinical medicine populations may be targeted by more than one interven-
and global health practice, 3) develop innovative partner-
ships for improved health sector outcomes, and 4) inform tion. A systematic review from researchers at the Pasteur
and empower health through outreach to the public.
Institute and Paris-Saclay University reviewed 63 articles,
40% of which evaluated antibiotic resistance, and found
that MDA/SDA interventions lead to greater AR preva-
lence, especially those involving co-trimoxazole and
azithromycin. The findings from this review underscore
the great need for guidelines for AR evaluation in the
context of MDA/SDA interventions. Source: CDDEP
THE PHARMA WORLD 101
INTERVIEW
Bangladesh Specialized Hospital is a complete
Super Speciality Hospital & Diagnostic Center
Al Emran Chowdhury and quality services to the patients Pathology & Lab Medicine De-
Director & CEO for comprehensive & integrated super partment of Bangladesh Specialized
Bangladesh Specialized Hospital, speciality services under one roof. Hospital has become the leading di-
Dhaka agnostic laboratory in Bangladesh by
What Plan do you have in mind virtue of its uniqueness in offering
As you have recently joined for development of BSHL? diverse tests, reliability and prompt
Bangladesh Specialized Hospital turnaround time. We provide state-
as CEO, we congratulate you. Now We are committed to run the hos- of-the-art reliable diagnostic services
tell us in brief about the hospital. pital based on corporate culture for 24 hours a day, 7 days a week, for pa-
advanced level of care in different tients, general practitioners and other
Bangladesh Specialized Hospital specialties as a center of excellence hospitals in the country. The depart-
started its journey in 2016. It’s a com- under one roof. We have a responsi- ment is also a regional and national
plete super specialty hospital & diag- bility to provide quality & cost effec- referral Centre for specialized tests.
nostic center in Bangladesh having tive health care services to the peo-
the state-of-the art facilities. First of ple of Bangladesh as well as to the Bangladesh Specialized Hospital’s
all, it started with 120 beds. Equipped foreigners. On the other hand, BSHL Radiology and Imaging department
with renowned physicians, trained is also a corporate hospital, so we comprises of the latest digital imag-
doctors and nurses, environment, it’s will ensure the health care services ing technologies designed to provide
reputation and identity spread quick- by providing the different corporate wide-ranging services together with
ly all around. In the continuation of facilities. Continuous learning and excellent patient care and service. A
which, on 27th July, 2019 BSHL was up- development is our objective. So we fully qualified and trained certified
graded to a total of 260 beds in a very are developing all our departments radiologists, technologists and care
short period of time to offer upgraded by renowned physicians, skilled nurse staff provide the utmost level of per-
& technicians brick by brick. sonalized care to every patient. All
reports are evaluated and supervised
Presently, which discipline by our reputed Consultant to ensure
BSH deals with? the accurate test reports for patients.
The Radiology & Imaging department
Presently, we are dealing with eve- provides extensive service to our pa-
ry discipline in respect of a modern tients with 128-slice CT scan, 1.5 Telsa
specialized hospital. Every physician MRI, 2D & 4D Ultrasonography with
who is here has earned enough repu- color Doppler facilities as well as X-
tation in the respective department. Rays. We have also introduced the
They are very committed to serve Long Term Video EEG for the first time
health care services efficiently & ef- in Bangladesh.
fectively. As a one-stop service organ-
ization, we are covering Cardiology, What are your future
Gastroenterology, Cardiac Surgery, plans for expansion?
Neuro medicine & Neuro Surgery, Or-
thopedics, Nephrology & Urology, Gy- In a very short period of time, the
naecology, Colorectal, ENT, plastic & hospital has extended 120 beds to 260
aesthetic surgery, 24-hour emergency beds. Besides, we have more plan for
with highly experienced specialists, expansion. The construction of our
consultants & nurses under one roof. adjacent building has already moved
forward. We hope, within a very short
Do you have the modern diagnostic time we can open our next building.
and pathological facilities There is also a plan to open branches
including Imaging services? of this hospital in the divisional cities
of the country.
THE PHARMA WORLD 103
FDA APPROVALS
Brand Name Generic Name Manufacturer Date of Treatment
Approval
Welireg Tablets Belzutifan Merck Aug 13, 2021 Von Hippel-Lindau (VHL)
Disease-Associated
Tumors
Nexviazyme Avalglucosidase alfa-ngpt Sanofi Aug 6, 2021 Nexviazyme
Lyophilized Powder (Avalglucosidase alfa-ngpt)
for Injection is used for the treatment
of Pompe disease.
Saphnelo Injection Anifrolumab-fnia AstraZeneca July 30, 2021 Systemic Lupus
Erythematosus
Twyneo Cream Tretinoin and Benzoyl Sol-Gel Technologies, Ltd. July 26, 2021 Treatment for: Acne
Peroxide
Bylvay Capsules Odevixibat Albireo Pharma, Inc. July 20, 2021 Progressive Familial
Intrahepatic Cholestasis
(PFIC)
Rezurock Tablets Belumosudil Kadmon Holdings, Inc July 16, 2021 Graft Versus Host Disease
Kerendia Tablets Finerenone Bayer HealthCare July 09, 2021 Chronic Kidney Disease
Pharmaceuticals Inc. Associated with Type 2
Diabetes
Rylaze Injection Asparaginase erwinia Jazz Pharmaceuticals plc June 30, 2021 Acute Lymphoblastic
chrysanthemi Leukemia
recombinant)-rywn
Verkazia Ophthalmic Cyclosporine Santen Inc. June 23, 2021 Vernal
Emulsion Keratoconjunctivitis
Astepro Allergy Azelastine Bayer HealthCare June 17, 2021 Allergic Rhinitis
Nasal Spray Pharmaceuticals Inc
Rezipres Injection Ephedrine hydrochloride Eton Pharmaceuticals, Inc. June 14, 2021 Hypotension
Soaanz Tablets (Torsemide) Sarfez Pharmaceuticals June 14, 2021 Edema
Prevnar 20 Injection Pneumococcal 20-valent Pfizer Inc. June 08, 2021 Pneumococcal Disease
conjugate vaccine Prophylaxis
Aduhelm Injection Aducanumab-avwa Biogen June 07, 2021 Alzheimer’s Disease
Wegovy Injection Semaglutide Novo Nordisk June 04, 2021 Treatment for Obesity
Company
Ryplazim Injection Plasminogen, human-tvmh Liminal BioSciences Inc June 04, 2021 Plasminogen Deficiency
Type 1
Tembexa Tablets (Brincidofovir) Chimerix, Inc. June 04, 2021 Smallpox
and Oral Suspension
Brexafemme Tablets Ibrexafungerp Scynexis, Inc. June 01, 2021 Vaginal Candidiasis
Lumakras Sotorasib Amgen Inc. May 28, 2021 Non-Small Cell Lung
Cancer
Myfembree Tablets Relugolix, Estradiol & Myovant Sciences May 26, 2021 Uterine Fibroids
Norethindrone Acetate
Camcevi Injection Leuprolide Mesylate Foresee Pharmaceuticals May 26, 2021 Prostate Cancer
104 THE PHARMA WORLD
GLOBE SCAN
Russian Pharmaceutical market
The Russian Pharmaceuti- Russian Pharmaceutical are some of the major distributors
cal market is one of the larg- Market Value in 2020:
est in the world valued at in the Russian market.
USD 20Bn in 2020 and expected to USD 20bn
touch $80Bn in 2030. In 2019, per Pharmaceutical distribu-
capita spending on medicines was Russian Pharmaceutical
$160 per person, placing Russia Market Value Expected tors provide access to foreign
19th out of 32 central and eastern
European (CEE) economies. $19.9 in 2030 drugs and allow for the distribution
billion worth pharmaceuticals
were sold in Russia in 2019, equal USD 80bn of drugs produced locally. Leaders
to 1.2% of GDP and 22.6% of the
nation’s health spending. Spending on medicines in this area—along with leaders in
is Expected to rise in
Russian Pharma Market very 2024 drug production—are quite stable,
much focuses on imported medi-
cines despite a strong domestic USD 27bn and the fifteen largest companies
pharmaceutical industry in Russia.
According to ITC Trade Map, the Manufacturers prefer to work control up to 78% of the market,
Russian imports of pharmaceuti- with distributors to promote their
cals is estimated to be USD 10.8Bn products to retail outlets. Distribu- a very high percentage relative to
in 2020. tors operate vast networks of con-
tacts and work to direct retail dis- international norms. The number
The Russian pharmaceutical tribution channels. Protek, Pulse,
market can be divided into pre- Katren, R-Pharm, Pharm Komplekt, of pharmacy chains is growing and
scription drugs and over the coun- Grand Capital, BCC, and Profit-Med
ter (OTC) medicines. Prescription currently exceeds 50,000.
drug sales have traditionally domi-
nated the market, and this trend
continued in 2019; prescription
medications represented 63.3% Factors of Demand
of sales. Of this amount, sales of
generics constituted 68.4% of Rus- Cardiovascular diseases, cancer
sian prescription sales in 2019.
and HIV are the most prevalent
diseases in Russia and are driving
demand for associated pharma-
ceutical products. High rates of
smoking and alcohol consump-
tion also contribute significantly
to illnesses. Per a 2015 WHO re-
port, 39.1% of the Russian popu-
lation smokes compared to a rate
of 22.7% globally and 27.3% in
Europe. In addition, per capita
alcohol consumption of 15.1 liters
of pure alcohol per year between
2008 and 2010 far exceeded the
global average of 6.04 liters.
Units: $ millions 2017 2018 2019 2020 estimated
Pharmaceutical Sales 20,088 19,263 19,859 19,254
Prescription drugs sales 12,280 12,005 12,566 12,345
OTC drugs sales 7,808 7,257 7,293 6,908
Generic drugs sales 8,236 8,115 8,589 8,539
Source: Fitch Solutions (formerly known as Business Monitor International)
THE PHARMA WORLD 105
APPOINTMENTS & PROMOTIONS
Mir Zaki Azam Chowdhury, a years as Marketing Manager. Later
veteran professional in Bangladesh he joined General Pharmaceuticals
pharma sector, has recently joined as Director Marketing and served
Goodman Pharmaceuticals as Director 29 years with outstanding track
Operations. He started his career in record. He completed his Honours
Opsonin Pharma in 1980. He worked and Masters in Political Science from
in Opsonin for six years with his Rajshahi University. A widely travelled
last designation there being Deputy man, Zaki Azam participated in many
Marketing Manager. He also worked professional trainings at home and
in Pharmadesh Laboratories for four abroad.
Wahid-Un-Nabi has recently Julkar Nain Khandaker has Md. Mahmudur Rashed has Md. Mahmudur Rahman
been promoted to Head of recently been promoted to recently been promoted has recently been pro-
Business Operation at As- Deputy Manager, SMD at to Assistant Manager, SMD moted as Group Product
tra Biopharmaceuticals Ltd. Astra Biopharmaceuticals. at Astra Biopharmaceuti- Manager, Strategic Brand
Previously, he was the Man- Previously, he was the Group cals Ltd. Previously, he was Management Department
ager, International Market- Product Manager in the same the Senior Executive in the in Organic Health Care.
ing & Regulatory Affairs in organization. He obtained same organization. He ob- Prior to this, he worked
the same organization. He his B. Pharm from State Uni- tained his B. Pharm from as Brand Manager in the
obtained his BBA & MBA versity of Bangladesh and M. University of Asia Pacific same department. Start-
from Eastern University. Pharm from UODA. and M. Pharm from UODA. ing his career in Supreme
Pharmaceuticals as Prod-
Sanjay Debnath has recent- ment. Starting his career uct Executive, PMD, he has
ly joined Organic Health in Kumudini Pharmaceuti- ten years of experience in
Care as Group Product cals, Sanjay has experience pharmaceutical market-
Manager, Strategic Brand of more than nine years in ing. Doing his B. Pharm
Management Department. pharmaceutical marketing. and M. Pharm from UODA,
Prior to this, he served in He obtained his B. Pharm he also obtained a profes-
Navana Pharmaceuticals as from Stamford University sional course on Advanced
Brand Manager, Strategic Bangladesh and M. Pharm Certificate in Business Ad-
Brand Management Depart- from UODA. ministration (ACBA) from
Bangladesh Institute of
Management (BIM).
106 THE PHARMA WORLD
APPOINTMENTS & PROMOTIONS
Mohammad Abul Basher Howlader Pharm and M. Pharm from University
has recently joined as General Man- of Dhaka and MBA from East West
ager, Marketing at Pharmasia Limit- University. He has around18 years of
ed. Prior to this, he worked as Deputy experience in the pharmaceutical in-
General Manager, Marketing at Radi- dustry.
ant Pharmaceuticals. He started his
career from Orion Pharma and per-
formed diversified functional & lead-
ership roles in Square Pharmaceuti-
cals & ACI. Basher completed his B.
Debashis Sarker Dipak has re- Syed Mustahid Hossain The road to success is always
cently joined Organic Health Bokhari has recently joined under construction.
Care as Brand Manager, Stra- Organic Health Care as
tegic Brand Management Senior Executive, Strategic – Lily Tomlin
Department. Prior to this, he Brand Management De- There is one rule for the
served in Navana Pharma- partment. Prior to this, he industrialist and that is:
ceuticals as Product Manager, worked in One Pharma as make the best quality goods
Product Management Depart- Senior Executive, Product possible at the lowest cost
ment. Starting his career in So- Management Department. possible, paying the highest
matec Pharma as Product Ex- Mustahid started his career wages possible.
ecutive, PMD, Debashish also in Apollo Hospitals Dhaka
worked in Novo Healthcare as Hospital Pharmacist. He – Henry Ford
Ltd. in the same department. obtained his B. Pharm and
He obtained his B. Pharm and M. Pharm from State Univer- THE PHARMA WORLD 107
M. Pharm from UODA. sity of Bangladesh.
Nasimul Islam has recently
joined Organic Health Care as
Senior Executive, Strategic Brand
Management Department.
Prior to this, he worked in Silva
Pharma, Nipa Pharmaceuticals
and Navana Pharmaceuticals in
PMD. He obtained his B. Pharm
from Atish Dipankar University of
Science and Technology and M.
Pharm and MBA from UODA.
Doctor’s Diary
Dr. Rafia Alam
Resident Medical Officer, Department of Neuro ICU, Square Hospitals, Dhaka.
Life vs death: life and death in a single frame
How could one assess life? Probably every thought The core of my mind was really stirred by the fatal aspect
is a relative one and can vary time to time. I real- of the pandemic, the sufferings of our patients and the
ized this very well in this pandemic situation. Be- pains of their relatives. I found myself sometimes unsta-
fore working in COVID ICU, I never realized the beauty of ble in terms of subjective feeling of peace on coming back
life in such depth. It is really a life time experience for me home just after my duties in COVID ICU. At those crucial
to work there. One can wonder, how could I explore life moments, my mind was diverted by caring of the greenery
amidst death? Well, sharing some experience with you all at my interior and having fun with my beloved pets. I also
would make a sense. had to worry regarding my parents’ health and their risk of
being infected with COVID-19 via myself. Not only me, each
Probably the declaration of a tragic death in COVID ICU and every COVID WARRIOR had the same kind of fear for
was the most pathetic event in this period for me. That their near ones, I think.
gentleman was just in his thirties. I had to tell the bitter
truth to his wife. I think I will never be able to forget her I can mention three of my hospital colleagues who lost
eyes while I was telling that her husband was no more. their near ones (i.e. either parents) in this period, who were
She was not ready to believe my words. There were no admitted into COVID ICU. I can remember some youth suf-
tears, no screaming out. The only-word I found to de- fering in COVID ICU, among them there were young preg-
scribe her is: diffidence. Other family members were in- nant ladies who were waiting for probably the sweetest
formed the truth earlier, but none of them could tell it to moments of motherhood, but had to pass the days in ICU
that young lady. I just wonder how lively the couple has beds. One had to come to COVID ICU after her caesarean
been then, if the man had been a COVID survivor. Life section, who could not even see her baby’s face yet. I my-
would surely be full of colorful dreams to the couple, to self called the nursery for the assurance of the mother that
the entire family. her child is alright there. Motherhood is one of the most
precious event in a woman’s life undoubtedly. Irony is, one
While working in Neuro ICU, one day one of the patients had her delivery while she was in COVID ICU in a life threat-
came and thanked Neuro ICU, who recovered there and ening condition, baby did not survive. I was not on duty
went home with a positive outcome. He returned to our at that moment, still I can’t forget the event after hearing
ICU only to thank the team. This might really surprise a from my colleague. I can remember a young boy, probably
junior doctor like me. I can mention other people whose 18 or 20 years old, died during my duty hour. I wonder how
near and dear ones were treated in ICU and they were the family could pass that extremely grievous time.
thankful for their patient’s recovery. I was even more as-
tonished while I was working in COVID ICU. A critical pa- Another part I want to mention just before ending up,
tient’s attendant thanked our doctor just for serving as are the moments of prayers from inside the ICU. The doc-
a COVID WARRIOR, though his own patient was not even tors praying just outside, patient’s relatives praying from
in the phase of recovery. His gratefulness and realization elsewhere. Everyone is trying their best, in a manner that is
of the serious risk issues of the health worker cannot be highest from their point. Though the source of the nutrition
counted in terms of wealth. is arranged by the hospital, I remember someone requested
to give the patient zamzam water (brought by the relative
It might sound interesting that the person who is shar- along with), someone requested to hang their holy cross
ing all these experiences as a ICU doctor, never thought to near the ICU bed, someone requested to give the offering
work in any ICU even in the beginning of 2019. But when of prayer (puja) to the patient. At the border of the life, all of
got the chance to work in Neuro ICU for the first time and them depend upon the creator.
had my view towards life totally change after 2 years. The
fight of the patients to grab oxygen in COVID ICU and their The creator, the most merciful has blessed us with life.
utmost endeavor just to have a full breath is really mys- Working as a doctor of ICU and seeing life and death par-
terious. I don’t know how to describe this to one who has allel in a single frame, I find life even more beautiful than
no experience of observing it by his own. I had to experi- earlier. Never to forget that life is tremendously beautiful,
ence these distressful events with my heart being broken. is my very own learning as a ICU doctor.
THE PHARMA WORLD 109
Tianjin Tianyao Pharmaceuticals Co., Ltd.
FIRSTThe company has become the prequalified API source of
WHODexamethasone and Dexamethasone Sodium Phosphate by
News from WHO official site:
Dexamethasone (WHOAPI-411) and Dexamethasone sodium phosphate (WHOAPI-412)
manufactured by Tianjin Tianyao Pharmaceuticals Co Ltd have been prequalified by the WHO
Prequalification Unit - Medicines Team (PQT/MED) under its API prequalification procedure.
WHOAPI-411 - Dexamethasone - Tianjin Tianyao Pharmaceuticals Co Ltd - CHINA
WHOAPI-412 - Dexamethasone Sodium Phosphate - Tianjin Tianyao Pharmaceuticals Co Ltd -
CHINA
FPPs containing Dexamethasone and Dexamethasone sodium phosphate are used in the
therapeutic area of COVID-19
These represent the first Dexamethasone and Dexamethasone sodium phosphate APIs to be
prequalified
Link:
https://extranet.who.int/pqweb/news/first-dexamethasone-and-dexamethasone-sodium-phosph
ate-active-pharmaceutical-ingredients-apis
Tianjin Tianyao Pharmaceuticals Co., Ltd., the leading company who is specialized in the
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USFDA with on-site inspections, the product line has been increasing over the years and more are
expected to come.
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Dexamethasone Sodium Phosphate USDMF & COS
COS applied Prednisone US on-site APPROVED, COS & TGA
Fluocinolone Acetonide COS & TGA
Hydrocortisone Acetate Prednisone Acetate USDMF
US on-site APPROVED & COS
Methylprednisolone USDMF Spironolactone US on-site APPROVED & COS
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